FDA Inspection 1187539 — Siemens Medical Solutions USA, Inc
The FDA completed an inspection of Siemens Medical Solutions USA, Inc on Oct 26, 2022 in Malvern, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 26, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Malvern, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 5905 | 21 CFR 1020.30(d) | Assembling, installing, adjusting, testing |